Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications

• Published in: Emerging infectious diseases Vol. 28; no. 3; pp. 672 - 683
• Main Authors: Stone, Mars, Grebe, Eduard, Sulaeman, Hasan, Di Germanio, Clara, Dave, Honey, Kelly, Kathleen, Biggerstaff, Brad J., Crews, Bridgit O., Tran, Nam, Jerome, Keith R., Denny, Thomas N., Hogema, Boris, Destree, Mark, Jones, Jefferson M., Thornburg, Natalie, Simmons, Graham, Krajden, Mel, Kleinman, Steve, Dumont, Larry J., Busch, Michael P.
• Format: Journal Article
• Language: English
• Published: United States U.S. National Center for Infectious Diseases 01.03.2022; Centers for Disease Control and Prevention
• Subjects: Algorithms; Antibodies; Antibodies, Viral; Antigens; Blood; Blood & organ donations; coronavirus disease; Coronaviruses; Correlation coefficient; COVID-19; COVID-19 - diagnosis; COVID-19 - epidemiology; COVID-19 vaccines; Estimates; Evaluation of Commercially Available High-Throughput SARS-CoV-2 Serologic Assays for Serosurveillance and Related Applications; Humans; Infections; Medical examination; Methods; Pandemics; Plasma; respiratory infections; Sample variance; SARS-CoV-2; Sensitivity and Specificity; Sentinel health events; Serodiagnosis; Serologic Tests - methods; Severe acute respiratory syndrome coronavirus 2; Testing laboratories; viruses; United States; United States > US; COVID-19; SARS-CoV-2; viruses; severe acute respiratory syndrome coronavirus 2; zoonoses; coronavirus disease; serologic assays; vaccine-preventable diseases; respiratory infections
• ISSN: 1080-6040; 1080-6059; 1080-6059
• DOI: 10.3201/eid2803.211885

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serosurveys can estimate cumulative incidence for monitoring epidemics, requiring assessment of serologic assays to inform testing algorithm development and interpretation of results. We conducted a multilaboratory evaluation of 21 commercial high-throughput SARS-CoV-2 serologic assays using blinded panels of 1,000 highly characterized specimens. Assays demonstrated a range of sensitivities (96%-63%), specificities (99%-96%), and precision (intraclass correlation coefficient 0.55-0.99). Durability of antibody detection was dependent on antigen and immunoglobulin targets; antispike and total Ig assays demonstrated more stable longitudinal reactivity than antinucleocapsid and IgG assays. Assays with high sensitivity, specificity, and durable antibody detection are ideal for serosurveillance, but assays demonstrating waning reactivity are appropriate for other applications, including correlation with neutralizing activity and detection of anamnestic boosting by reinfections. Assay performance must be evaluated in context of intended use, particularly in the context of widespread vaccination and circulation of SARS-CoV-2 variants.